Field of the Disclosed Subject Matter
The disclosed subject matter relates to a system for treating endovascular irregularities and repair. Particularly, the present disclosed subject matter is directed to a medical device for use within the aorta.
Description of Related Art
Aortic aneurysms are a common deteriorating disease typically manifested by a weakening and expansion of the aorta vessel wall. Aneurysms affect the ability of the vessel lumen to conduct fluids, and may at times be life threatening when, for example, rupture of the vessel wall occurs. A standard treatment for repairing an aneurysm is to surgically remove part or all of the aneurysm and implant a replacement prosthetic section into the vessel.
The aorta is the major artery that carries blood from the heart to the rest of the body. FIG. 1 is a schematic illustration of the aorta 100 and the heart 108. The aorta 100 includes an ascending aorta 102, an aortic arch 104, and a descending aorta 106. The ascending aorta 102 is the first segment of the aorta 100 where the aorta 100 originates from the heart's left ventricle. Coronary arteries 110 originate at the aortic root 111. The brachiocephalic artery 116, the left common carotid artery 118, and the left subclavian artery 120 branch from the aortic arch 104. The descending artery 106 extends past the diaphragm 112, leading to the abdominal aorta 114.
Aortic dissection occurs when the inner layer of the aorta's artery wall splits open (dissects). This is more likely to occur where pressure on the arterial wall from blood flow is high, such as in the ascending aorta 102. FIG. 2 shows a dissection 122 in the ascending aorta 102. The dissection may be caused by a tear 124 in the aortic wall. When the layers of the aortic wall split open (separate from one another), it creates a false lumen 126 through which pulsatile blood flow can access the inner layers that compose the arterial wall.
The flow of blood through this false lumen, and the resulting increase in pressure, can exacerbate the dissection and cause further tearing. The standard surgical approach in patients with ascending aortic aneurysm or dissection involving the aortic root and associated with aortic valve disease is open heart surgery including the replacement of the aortic valve and ascending aorta. Acute type A dissection is categorized as a surgical emergency with a 1% mortality per hour, and an average operative mortality of 30%. In patients who have multiple comorbidities, hemodynamic instability or malperfusion and end-organ dysfunction, aortic root replacement for the above indications carry significant operative mortalities and morbidities.
Numerous endovascular devices are known to treat varying aspects of heart valves and aortic root repair, including U.S. Patent Publication Nos. 2009/0270965, 2009/0264993, 2012/0130472, 2006/0195177 and U.S. Pat. No. 6,723,116, each of which is hereby incorporated by reference in its entirety.
There thus remains a need for a safe and effective method and system for an endovascular bioprosthetic valve-conduit as aortic root replacement in this acutely ill and high risk patient population. The device and methods disclosed herein can be implanted expediently via a catheter-based approach on a beating heart, avoiding potential morbidities associated with an open heart procedure.